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510(k) Data Aggregation

    K Number
    K170820
    Device Name
    Capnograph and Oximeter
    Manufacturer
    CMI Health Inc.
    Date Cleared
    2018-07-18

    (485 days)

    Product Code
    CCK, DQA
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMI Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Capnograph and Oximeter is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate. The Capnograph and Oximeter is intended for use in adults in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.
    Device Description
    This device is used to monitor up to four physiological parameters for the patient at the same time: End tidal CO2 concentration (EtCO2), Respiration Rate (RR), functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The monitor can be purchased having functions with two or more of the parameters mentioned above, but the manual can be used for the device in any configuration. The Capno-H uses an infrared absorption method to measure in a sidestream or Mainstream mode. The measurement parameters are EtCO2, InsCO2 and Respiration Rate. InsCO₂, also called FiO₂ is the fraction of oxygen in the volume being measured. The CO2 response time is Sidestream: <3seconds (includes transport time and rise time) and Mainstream: <60ms (rise time). The unit of measurement is mmHg, kPa or Vol%. The CO2 measurement range is EtCOz: 0~150mmHg and InsCO₂: 3~50mmHg. The SpO2 measurements are also determined by infrared absorption. The measurement range is 0-100% at an accuracy of ±3% for SpO2 range from 70 -100% with a pulse rate range of 30-240 bpm at an accuracy of +/- 2bpm or +/- 2% (whichever is greater). For SpO2 and bpm, there are configurable high and low alarms.
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